Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Model 4968 Participants | All Model 4968 participants in the analysis cohort | None | None | 30 | 349 | 0 | 349 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Over-sensing | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| High impedance | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Insulation breach | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Lead conductor fracture | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Failure to capture/loss of capture | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Threshold rise, Sudden | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Failure to sense | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |